MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number G7750444

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 01/23/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior spinal surgical procedure at c2-t7.It was found post-op that the cranial rods disengaged from the dominoes on both sides.A revision was performed 8 days post-op to reconnect the rods with new dominoes.No additional patient complications were reported.

Manufacturer Narrative

(b)(4).This part is not approved for use in the united states; however, a like device catalog # 7750444, 510k # k090714 was cleared in the united states.The device was not returned for evaluation however films were supplied for review which found: ap view of complex construct extending from the upper cervical spine to mid thorax c2-t7.Subsequent film is also an ap showing disengagement of the vertex system and the thoracic system at the lateral connector on one side.There is some displacement of the rod suggesting some loss of correction.Surgical staples are still in place suggesting a very immediate postoperative complication.

Manufacturer Narrative

Implant returned without associated rods or set screw sub-components.Unable to provide additional analysis without either of the attachement components.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3636914
• MDR Text Key: 3983829
• Report Number: 1030489-2014-00535
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G7750444
• Device Lot Number: 0169405W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RODS, SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 00076 YR
• Patient Weight: 68